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1.4. Further guidance and support to facilitate the implementation of QbD
Further guidance has also been provided in June 2011 by the POINTS TO CONSIDER,19 an ICH-Endorsed Guide for ICH Q8/Q9/Q10 for topics lacking clear interpretation. The ICH Working Group generated training materials and a comprehensive case study (for NCE drug compound and drug product) to help companies to understand the principles of QbD and how to implement these. It also outlined the interrelationship of Q8, Q9 & Q10 throughout the lifecycle and generated key messages on four topics: Design Space, Control Strategy, Pharmaceutical Quality System and Quality Risk Management.
19 ICH; Points to Consider ICH Endorsed Guide for Q8/Q9/Q10; 2011